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BIOPRO, INC.

Last updated September 17, 2026

Information

Country: US
Address: 2929 Lapeer Rd, PORT HURON, MI, 48060
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1832656
DUNS Number: 618749857

Catalogue (3006)

Page 15 of 61

Device	Model / Reference	Registries	Class	Status
MVA Cortical Locking Screw, 3.0mm x 10mm Sterile	20775	FDA UDI	Class II	Active
5 Mm Bone Screw X 52 Mm	21423	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 55mm	21234	FDA UDI	Class II	Active
Insert Total Mod 20x86	10380	FDA UDI	Class II	Active
Goez Screw 3.5 X 40mm	18220	FDA UDI	Class II	Active
Stem Pc Lg 12	11566	FDA UDI	Class II	Active
Tray Uni Comp Lg	14148	FDA UDI	Class II	Active
5 Mm Bone Screw X 78 Mm	21619	FDA UDI	Class II	Active
Horizon Titanium Subtalar 10mm	17223	FDA UDI	Class II	Active
Goez Screw 2.0 X 12mm	18165	FDA UDI	Class II	Active
34mm X 3.0 Hbs Std Ft Pkg	22552	FDA UDI	Class II	Active
Cortical Locking Screw 4.0mm x 80mm	20851	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 34mm	21543	FDA UDI	Class II	Active
Staple 4 Leg 14x12x15	18064	FDA UDI	Class II	Active
3.5 x 42mm Go-EZ Screw	18221	FDA UDI	Class II	Active
MVA Cortical Locking Screw 2.8mm X 22mm	20563	FDA UDI	Class II	Active
Toe Joint Mpj 2nd5th 8.75mm	16867	FDA UDI	Class II	Active
Anterior Lateral Tibia Plate 8 Hole, right	21167	FDA UDI	Class II	Active
16mm X 3.0 Hbs Screw Sdst Pkg	20519	FDA UDI	Class II	Active
TOE JOINT NPC 8.75mm	16867	FDA UDI	Class II	Active
Cortical Screw 2.8mm X 32 mm sterile	21515	FDA UDI	Class II	Active
10mm Nail Cap	21434	FDA UDI	Class II	Active
Medial Distal Column Plate, long	20908	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 12mm Sterile	21005	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 10.5 MM	22390	FDA UDI	Class I	Active
14mm Fusion Nail, Right	21599	FDA UDI	Class II	Active
Cortical Screw 3.0mm x 14mm Sterile	20995	FDA UDI	Class II	Active
Trial 10MM	17192	FDA UDI	Class I	Active
Cortical Locking Screw 3.5mm x 65mm	21320	FDA UDI	Class II	Active
Endo Modular Ceramic Sh 43	13008	FDA UDI	Class II	Active
Cortical Screw 3.5mm x 60mm, Sterile	21260	FDA UDI	Class II	Active
6.5 x 95mm Go-EZ Screw	19667	FDA UDI	Class II	Active
Hbs Screw 3.0 X 20mm Sdst	20521	FDA UDI	Class II	Active
10mm X 3.0 Hbs Std Ft Pkg	22540	FDA UDI	Class II	Active
Toe Porous Coated W/Hole Lg	17749	FDA UDI	Class II	Active
Open Wedge Plate 0mm Sterile	20724	FDA UDI	Class II	Active
Cortical Locking Screw 3.5mm x 30mm Sterile	21030	FDA UDI	Class II	Active
13mm Nail Cap	21622	FDA UDI	Class II	Active
BioPro	22860	FDA UDI	Class I	Active
HEAD FEMORAL 28mm +18	19010	FDA UDI	Class II	Active
Rod Tibial Medullary 9x50	10339	FDA UDI	Class II	Active
Effi+pro Ratchet	20191	FDA UDI	Class I	Active
38mm X 2.5 Hbs Screw Sdst	20319	FDA UDI	Class II	Active
Straight Low Contact Locking Plate 4 Hole	21129	FDA UDI	Class II	Active
FLEXIBLE REAMER WITH Multiple Flute TIP, 15 MM	21710	FDA UDI	Class I	Active
L-Shaped Fracture Plate 3 holes left 2.5/2.8mm	20620	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.5mm x 26mm Sterile	21012	FDA UDI	Class II	Active
THUMB MOD STEM COBALT TPS 11.5mm	17599	FDA UDI	Class II	Active
MVA Cortical Locking Screw 3.0mm x 38mm	21558	FDA UDI	Class II	Active
Insert Total Mod 12x82	15042	FDA UDI	Class II	Active

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FDA Recalls (39)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 9, 2025	Z-0148-2026	—	open, classified	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Sep 9, 2025	Z-0149-2026	—	open, classified	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Sep 9, 2025	Z-0151-2026	—	open, classified	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Sep 9, 2025	Z-0153-2026	—	open, classified	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Sep 9, 2025	Z-0150-2026	—	open, classified	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Sep 9, 2025	Z-0152-2026	—	open, classified	Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Feb 1, 2022	Z-0684-2022	—	terminated	There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0683-2022	—	terminated	There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0686-2022	—	terminated	There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0685-2022	—	terminated	There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0688-2022	—	terminated	There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0691-2022	—	terminated	There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0690-2022	—	terminated	There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0687-2022	—	terminated	There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0689-2022	—	terminated	There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Feb 1, 2022	Z-0682-2022	—	terminated	There is an incorrect statement regarding MR Compatibility in the BioPro Titanium MPJ implant IFU (IFU BP102303 rev 05) and patient implant cards (22266 rev 00) which indicates that the BioPro MPJ Implant has been tested for safety and compatibility in the MR Environment and is MR Conditional. MR Testing has not been conducted on the titanium version of the MPJ.
Jun 25, 2019	Z-2256-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2249-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2253-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2241-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2254-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2243-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2244-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2257-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2252-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2259-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2239-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2250-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2255-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2258-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2248-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2251-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2246-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2242-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2245-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2240-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Jun 25, 2019	Z-2247-2019	—	terminated	Manufacturing flaw in the sterile barrier system
Sep 21, 2011	Z-0164-2012	—	terminated	BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.
Sep 21, 2011	Z-0163-2012	—	terminated	BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility.